Adjunctive Study of AL-37807 Ophthalmic Suspension
The purpose of the study is to compare the safety and IOP-lowering efficacy of AL-37807, 1% vs. Timolol Gel Forming Solution, 0.5% vs. Vehicle all dosed QD AM, all dosed concomitantly with Xalatan QD PM in patients with open-angle glaucoma or ocular...
Brief Summary
Official Title: “Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension”
The purpose of the study is to compare the safety and IOP-lowering efficacy of AL-37807, 1% vs. Timolol Gel Forming Solution, 0.5% vs. Vehicle all dosed QD AM, all dosed concomitantly with Xalatan QD PM in patients with open-angle glaucoma or ocular hypertension
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: July 2008
Intervention(s) in this Clinical Trial
- Drug: AL-37807
- Active drug
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- AL-37807
- Active Comparator: 2
- Timolol Gel Forming Solution
- Placebo Comparator: 3
- Vehicle
Outcome Measures for this Clinical Trial
Primary Measures
- Mean IOP change from baseline
- Time Frame: from baseline
Safety Issue?: Yes
- Time Frame: from baseline
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- open-angle glaucoma
- ocular hypertension
- Must have been on Xalatan for at least 3 months
- VA not worse than 0.60
Exclusion Criteria:
- Age related
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Alcon Research Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620256
Study ID Number: C-07-05
ClinicalTrials.gov Identifier: NCT00620256
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00620256
